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Clinical trials that are designed to help inform practice in the real world are referred to as pragmatic trials. They are often described as focusing on practical aspects of designing a study that include recruitment and consent, adherence and the use routinely available equipment.
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A pragmatic trial that uses various investigators and participants from diverse geographical locations is the Home Blood Pressure Management study (HBPM). This kind of heterogeneity is essential for pragmatic trials to be valid and also helps to reduce bias in the results. However too much heterogeneity could result in issues with the design of the trial.
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Pragmatic trials aim to mimic real-life settings and achieve maximum external validity. They are typically ordered by policymakers and practitioners in order to guide their decisions. They can also be used to determine the causality of an intervention with its outcomes. However, they shouldn't be used in lieu for the use of explanation studies.
The concept of pragmatism is controversial and there are doubts about whether pragmatic trials should replace or complement them. Schwartz and Lellouch1 suggested a distinction between explanatory trials, which confirm a physiological or clinical hypothesis as well as pragmatic trials, which inform the practice and policy decisions. They also suggested a framework dubbed PRECIS for pragmatic trials.2 This tool tried to define the elements of a pragmatic research study which includes the recruitment, design, and delivery of the intervention and follow-up.
The number of pragmatic trials is increasing. A recent Medline search using the terms pragmatic and naturalistic, restricted to controlled trials that are randomized (RCTs) resulted in 34 articles, as shown in red in Figure 2. This is a sign that the health sciences community is becoming more sensitive to the issue of pragmatism. It is important to keep in mind that the majority were conducted in primary care settings.